Q3 2021 Gamida Cell Ltd Earnings Call
Ladies and gentlemen, thank you for standing by welcome to the <unk> meter sales conference call for the third quarter 2021 financial results. My name is Henry and I'll be your operator for todays call. Please be advised that this call is being recorded Demeter sells request.
Now I would like to introduce your host for today's conference Mr. Josh Hamermesh Chief Business Officer, Sir. Please go ahead.
Thank you Henry and good morning, everyone welcome to today's call during which we will provide an update on the company and review our financial results for the third quarter of 2021 earlier.
Earlier. This morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at www Dot <unk> Dot com.
Here with me on our call today are Julian Adams, Chief Executive Officer, Ronit Cementos, our Chief Medical Officer, Michelle Kaufman, Chief operating Officer, and Chief Commercial Officer, Shai Lynn <unk>, Chief Financial Officer, and Additionally, jazz awful, our chief regulatory and quality officer will join for the QE.
<unk> session following our prepared remarks.
During this call we may make forward looking statements about our future expectations and plans, including in respect of the timing of initiation and progress of and data reported from our clinical trials of our product candidates anticipated regulatory filings, including the submission of the BLA for <unk> to the FDA.
Commercialization planning efforts, the potentially life, saving or curative therapeutic and commercial potential of <unk> and our expectations regarding our projected cash to be used for operating activities and cash runway. Our actual results may differ materially from what we project today due to a number of important factors, including the <unk>.
Impact of COVID-19 on our operations the scope progress and expansion of our clinical trial and cost impact thereof, clinical scientific regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics and in the index.
Or are building a business around such products as well as those considerations described in the risk factors section of our most recent annual report on form 20-F, and other filings that we make with the SEC from time to time.
These forward looking statements represent our views only as of today and we caution you that we may not update them in the future whether as a result of new information future events or otherwise.
Now I'd like to turn the call over to Julian.
Thank you, Josh and thanks to everyone for joining us this morning.
This was an important quarter for <unk> to sell as we continue to advance our mission of bringing potentially curative patient.
Potentially curative cell therapies to cancer patients.
We are at a crucial inflection point.
In the field of cell therapy, where.
Where we're starting to see multiple development programs that offer the potential for clinical benefit for patients with hematologic malignancies and serious blood disorders.
I am proud that <unk> is at the forefront of this research with our two advanced clinical stage Nam enabled cell therapy programs.
Oh, Madhu, Michelle and GDA 201.
We also recently expanded our pipeline of genetically modified them enabled NK cell construct and we are excited about sharing new data and developments on our cell therapy pipeline at major.
Multiple major international medical meetings this quarter.
Let me start today's call with an update on our lead program <unk>, which has breakthrough therapy designation and the potential to be the first FDA approved cell therapy for hematopoietic stem cell transplant.
<unk> is supported by a robust body of evidence, including positive phase III results, demonstrating strong efficacy and important benefit to patients in need of a bone marrow transplant.
We recently had a pre BLA meeting during which the FDA requested that gamete itself provide.
Revised analysis of the analytical data generated at gamete of cells wholly owned commercial manufacturing facility in Israel to.
To demonstrate comparability to the <unk> batches that were produced.
At the clinical manufacturing sites for the Phase III study.
We are confident that we can execute the analytical comparability that the FDA has requested in a timely manner to enable a BLA submission in the first half of 'twenty two.
It is also important to note that the FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated.
In collaboration with the FDA, we will work towards our BLA submission.
To bring <unk> to patients as soon as possible.
Moving to our NK cell pipeline. It is extremely exciting to be at the front at the forefront of the cutting edge research.
<unk> is being conducted.
In the emerging field of NK cell therapy.
NK cells have tremendous promise for treating cancer.
NK cells are the body's first line of defense, providing innate immunity and have immune privilege properties that obviate the requirement for Donnie donor matching.
Which can lead to a cryopreserved off the shelf product for patients.
The most advanced candidate in our NAV enabled NK pipeline GDA 201, Leverages, our proprietary NAV technology platform in the expansion of NK cells to enhance their functionality.
Correct tumor cell, killing properties and antibody dependent cellular cytotoxicity or <unk>.
GDA 201 has produced truly remarkable results.
Phase one investigator sponsored study, where we have seen very high and durable responses in both follicular lymphoma, and diffuse large b cell lymphoma.
As we have previously reported the phase one study had an overall response rate of 74%.
68% complete response rates.
And then impressive duration with several patients maintaining their complete responses for over two years after treatment.
During the third quarter, we submitted an IND application for the year to the FDA for a phase <unk> trial with a cryopreserved formulation in patients with diffuse large b cell lymphoma, and Follicular lymphoma.
Before initiating a clinical study we must address the clinical hold.
By responding to the Fda's questions about donor eligibility procedures and.
Sterility assay qualification.
We believe these questions are addressable and we plan to respond expeditiously to enable IMD acceptance.
And patient enrollment.
Due to the clinical hold the initiation of the phase one two trial will occur in 2022.
We will provide an update and additional guidance on timing when we have further clarity from the FDA.
This quarter, we made progress advancing.
Our genetically modified NIM enabled NK cell therapy programs.
Which utilized car and CRISPR mediated strategies to increase targeting potency and the persistence against hematologic malignancies and solid tumors.
We were excited to highlight these new programs at an R&D day in October.
Importantly, we are pleased to announce a receipt research collaboration with the Dana Farber Cancer Institute for our <unk> 601 cell therapy, which is a CD 38 CRISPR knockout.
Combined with the CD 38 car NK cell construct that has demonstrated promising preclinical results against multiple myeloma cell lines.
Together with Dana Farber, we will be studying that great potential.
<unk> 601 in multiple myeloma.
Our Nam enabled NK product candidates hold tremendous promise for both hematologic cancers, and solid tumors and we look forward to advancing our work in this very important field.
I want to conclude my introductory remarks.
By expressing my gratitude to our employees for their dedication and hard work towards driving forward our important mission.
The continued determination and focus on patients have brought us to where we are today.
And with that I will turn the call over to Ron <unk>, Our Chief Medical Officer.
Thank you Julian and good morning, everyone. Thank you for joining us on our call.
I'm excited to join you. This morning and describe the recent data we presented at the society for immunotherapy of cancer or 15 36 annual meeting.
Additionally, I will provide a preview on what we'll be presenting at the upcoming 63rd annual meeting of the American society of hematology or ash.
The data presented at 50 provided extensive characterization of the activity of GDA 201 by examining the phenotype, killing capacity and anti tumor activity of the cell.
The data showed that GDA 201 features a unique phenotype characteristic of a rejuvenated NK cells or non exhausted phenotype. According to classical lineage stages, retaining potent anti tumor effect in vitro and in vivo assay.
We also presented data, where we use artificial intelligence to analyze differentially expressed genes and metabolites and GDA 201, or NAND enabled NK cells.
The data illustrated the network of interactions associated with the enhanced biological function of Nam enable then Kay with increased cytotoxicity.
Homing and superior in vivo anti tumor ability compared to NK cells that workbench without ma'am.
These data give us key insights into the mechanism of action of NAV enabled NK cell expansion, which is important as we move GDA 201 into the next phase of clinical development and relevant to the cell therapies, and our expanding NK cell pipeline.
We're also very much looking forward to the presentations that we have coming up at the Ash meeting, which will be held on December 11th to the 14.
So I went through the sale, we will have an oral presentation on immune reconstitution as well as two poster presentations one with long term follow up data in patients treated with all into the cell and one on hospital and health care resource utilization.
Additionally for GDA 201, we will have a poster presentation with two year follow up data from the phase one study.
Hey, do we plan to pause that demonstrated that patients treated with only do the sell had more rapid recovery of a wide variety of immune cells associated with a lower risk of infection.
Additionally, on the <unk> treated patients had significantly shorter durations of hospitalization intensive care unit time consultant visit procedures and transfusion.
And an analysis of outcomes of patients with hematologic malignancies treated with only didn't sell over a 10 year period patients show long term sustained bone marrow function and immune recovery.
Taken together these data provide further evidence of the strong clinical benefit associated with more rapid and lasting hematopoietic recovery with only do the sale.
So GDA 201, we will share our two year follow up analysis from the investigator led study in patients with non Hodgkin lymphoma.
Demonstrating a medium duration of response of 16 months and 78% overall survival at two years with reported toxicities in line with those seen previously.
These data further strengthen our confidence in the safety and activity of GDA 201, Theyre further details about each of the presentations in the press release, we issued this morning, and we plan to provide further updates during ash.
Regarding the clinical program in GDA 201 colleagues on my team are preparing for the initiation of a multicenter study in patients with non Hodgkin lymphoma with operational activities and meetings with investigators and thought leaders ongoing.
We continue to hear from experts that there is a high unmet need among patients with lymphoma, who have active disease after a previous treatment.
Investigators are enthusiastic about beginning to enroll patients in this study in treating patients with GDA 201.
I'll now turn the call over to Michele <unk>, our Chief operating officer, and Chief Commercial Officer, who will talk more about our commercial opportunity for <unk> Michelle.
Thank you Ronnie and good morning, everyone. We remain excited about the opportunity from a <unk> to provide an important option to patients who need a bone marrow transplant and do not have a suitable matched donor.
In the U S alone there are over 40000 patients per year with hematologic malignancies, who consider a bone marrow transplant.
Unfortunately, only approximately 10000 patients are able to make it to transplant for a variety of reasons.
We have done extensive research in collaboration with the center for international Blood and marrow transplant research or CIP MTR conducted independent market research and spoken to hundreds of transplant, there's two fully assessed the unmet need.
Based on these commercial insights the opportunity from a <unk> can be summarized into two key categories. The first one is increasing access for patients, especially those who are eligible for transplant and cannot find a match.
Second improving outcomes based on the unmet clinical needs with current donor sources that can be addressed by on the data itself.
One specific area of advantage from a deep itself is that it has a less stringent matching criteria for patients as compared to graph sources from mats related or unrelated donors.
This is particularly important for patients of non Caucasian descent, who tend to have a more challenging time, finding a suitable matched donor.
Data from B the match highlight that a patient ethnic background greatly impacts his or her ability to find a match with some patient groups facing only approximately a 20% likelihood of finding a match in the public matching database.
Oh, Madhu, but so phase III trial over 40% of the patients enrolled were not Caucasian illustrating the important need for a suitable graph sourced in this patient population.
Upon FDA approval or potential FDA approval, we believe <unk> will provide a timely and attractive option for a suitable graft source to patients in need of a bone marrow transplant, who would otherwise undergo a search for a match donor that could take several months, causing high levels of anxiety and uncertainty for PAH.
<unk> with cancer, who are at high risk for relapse.
In our clinical trials, we consistently delivered on the <unk> itself the sites within 30 days of cord blood units selection.
Based on our extensive assessment of the market opportunity. We anticipate there will be approximately 2400 patients receiving on the deeper sell each year. Once we reach peak market share, which would be about three years after launch.
We anticipate this peak market share to be between 20% to 25% of the addressable patients.
We continue to have active dialogue with physicians and payers and feedback on the value proposition of armour deep itself has been highly encouraging specifically from payers. They are encouraged by the potential for faster time to neutrophil and craftsman decreased infections decrease in hospitalization and less graft versus host disease as.
Two published literature for other graph sources.
Now in my role as Chief operating Officer, let me transition to discuss the ongoing activities to address the fda's feedback about our analytical comparability data to enable the <unk> BLA submission.
Under the leadership of Vladimir Melnikov, our senior Vice President Global manufacturing and operations. We have completed the production runs for BLA readiness and the team is now conducting the revised analysis. The FDA has requested to demonstrate that the ahmedou self produced and gamete of cells wholly owned commercial manufacturing facility.
In Israel is analytically comparable to the <unk> that was produced at the clinical manufacturing sites for the Phase III study.
We feel that the analysis that the FDA has requested is addressable and we look forward to working with the FDA to complete the requirements to enable the BLA submission.
Transitioning to GDA 201.
There was a great unmet need for relapsed refractory patients with lymphoma in the U S and U five there are approximately 40000 patients who reach at least their third line of treatment.
During our discussions with both U S and EU physicians they were consistent with the challenges they see with their current treatment options and relapsed refractory lymphoma.
These included the need for therapies that balance efficacy, especially complete responses with a tolerable safety profile.
In addition, physicians discuss the importance of new therapies with improved duration of response.
GDA 201 clinical data received positive feedback from physicians and payers in a global assessment, including the balance of encouraging overall and complete responses and the safety data that included no cytokine release syndrome, and no neurotoxicity, which are often seen with other cell therapies.
Although there have been advances for patients with lymphoma, there's still significant unmet need in relapsed refractory patients that GDA 201 could address.
In summary, we are excited by the potential of <unk> to be the first FDA approved cell therapy for bone marrow transplant and we are encouraged by the clinical data and feedback from physicians and payers.
Finally, we are confident that we can address the fda's feedback from our pre BLA meeting to enable the BLA submission in a timely manner.
We are also very encouraged by the initial GDA 201 data that Rooney discussed and recognize the opportunity to further develop a new therapy for patients with relapsed refractory lymphoma.
Thank you and I will now turn the call over to Shai to review our financial results.
Thank you Michelle and good morning, everyone today, I will summarize our financial results for the third quarter of 2021.
As of September 32021, our total cash position was $128 million.
$127 2 million as of December 31st of last year.
As far as our total expected cash use for this year and the cash runway going forward I can share that we are actually be reassessing, our financial expenditures and previous financial guidance due to the updated timing.
Do we see a BLA submission and we will be updating our previous financial guidance.
Research and development expenses for the quarter with $12 $4 million compared to $10 $5 million for the same period in 2020 increase was mainly due to only to be sort of commercial manufacturing readiness activities and the advancements of the GDA 201 program, including broadening scientific capabilities and talent.
Commercial expenses in the quarter were $6 million compared to $1 $9 million for the same period last year. The increase was mainly attributed to progress its only to be sort of commercial readiness activities.
Going forward following the FDA recent feedback we are reassessing, our commercial readiness expenditures.
General and administrative expenses were $4 8 million during the third quarter of 2021 compared to $2 $7 million for the same period in 2020.
The increase was mainly due to professional expenses and the island with key management position to support the business and quotes.
Finance income net was three $5 million for the quarter compared to zero point $3 million in the same period last year.
The increase was primarily due to noncash income, resulting from revaluation of warrants.
By convertible note interest expenses.
Net loss for the quarter was $19 $6 million compared to a net loss of $14 $8 million for the same period last year.
We look forward to providing an update on our financial guidance as soon as they are able to do so we did I will turn the call back over to Julien.
Yeah.
Thanks Shai.
I'm proud to be part of a team that is working towards a very important mission to develop cures for patients with hematologic malignancies and blood disorders.
We're excited for the opportunity to continue to leverage our unique Nam enabled platform across a broad range of cell therapies. So that we can fulfill our promise to deliver potentially curative approaches to cancer patients in need.
With <unk>, we are working towards our BLA submission in the first half of 'twenty, two and continue to prepare to be launch ready at the time of approval.
We are excited about the potential for GDA 201, and are working with the FDA to resolve their issues and initiate a gamete itself sponsored clinical study.
Lastly, we are excited by our genetically modified NK cell products and look forward to providing further updates.
Now we will open up the call for <unk>.
Questions operator.
Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.
Your first question comes from Ted <unk> of Piper Sandler Your line is now open.
Great. Thank you so much for taking my question.
I just wanted to ask with respect to the door. The analysis, how big of an issue is this appreciated that this remember this whole clinical requirements or anything along those lines.
You know again with the understanding that your anticipation is to file in the first half is this pretty routine stuff, maybe you can give us a little bit more color. Thanks, so much guys.
Okay. Thanks, Thank you for your question.
It's a pretty tactical.
Answer.
To get into details and we won't get into the FDA.
Wrecked feedback.
Feedback, but at a higher level, we do not have to do additional.
Experiments, we just have to re analyze our data and I think.
From where I understand the FDA.
It's that it's a pretty routine situation for them.
Great. Thank you and then just to get a sense with respect to the Israeli manufacturing facility and bringing everything in house, what kind of supply would you be able ultimately to deliver.
From Israel.
And would that be both Brazil, and ultimately GDA 201, thanks, so much.
Thank you for your question.
We have built a state of the art facility in Israel.
With room to expand.
And let me, let me ask Michel to further elaborate on this.
On the state of this facility.
Thank you Julian and good morning, Ted.
So yes. This is Julian indicated the Israeli facility is state of the art and we built it in a modular approach. So we have the ability to add additional cores as needed. So from the standpoint of our addressing demand. We feel confident that we will have the capacity because we do have that ability to be modular and add coolers.
And we built the facility with the vision for both on the do the sell and the NK platform. So do the sell as we've discussed we're in the process of finalizing our BLA readiness requirements from a day to sell them and getting ready for commercial manufacturing. The production team is also working very closely with the R&D team to initiate the.
<unk> transfer from a research facility to our facility in Israel, the commercial manufacturing facility for the NK platform. Initially first GDA 201, so that was the vision for the the facility was both on the type of cell in the NK platform.
Thanks, Michele Thanks Julien.
Pleasure.
Your next question comes from Jonathan Miller of Evercore. Your line is now open.
Alright, thanks, so much guys.
And congrats on the progress its still seems odd to me that the FDA cleared the IND and then hold dosing.
That issue of all prior to patient dosing. So maybe could you give some color on what interactions you've had since the hold came on maybe get some clarity on like what the official status of that <unk> is at the moment.
If you recall a few weeks ago in the R&D day, you thought you said you thought it would be relatively quick process to give them. The analysis that they wanted to I just wanted to check in on what your progress was was there and then secondly on.
On the <unk> I noticed the healer abstract at Ash, which I always love to see.
But of course this is being pulled it looks from a lille so just versus cord blood.
Can you give us some color on what you've done.
Omi versus other graph sources that are in maybe in the U S and the EU are responsible for a greater proportion of overall HDD.
Thanks.
Okay, John I will try to address all three of your questions, but in such a way as let me.
Jazz to comment.
What we can share with the FDA interactions.
Vis vis the GDA 201 clinical hold.
Thank you Julien because we just see.
Okay.
Our confidence that we will be able to put glass, even given the pipeline that's already been made but Teresa Jose beat the FDA consent.
Things have now been qualified for the drug product Fda's request and it was a new lab has been identified that would help address fda's comment regarding Dana eligibility.
Thing that I could pay a glass.
Ben had no need perhaps you can also show a clinical update.
In terms of the clinical update yes. So we are continuing to work with the site.
To move forward with the clinical.
Protocol.
And the operational activities needed to initiate the phase officially so that one.
I am the hold is lifted we can just move forward to site initiation and then patient enrollment in our clinical protocol point of view, we have no. Other changes that we're making at this point and were just proceeding with the operational pieces.
And Ronnie since we have you on the line can you also comment on the AQR.
Question in the abstract and what can we extrapolate that to other modalities.
Yeah absolutely.
So we are.
A T O R analyses the first one that is that.
That will be presented at ash.
Is a utilization analysis that looks at resource utilization and patient pool.
Cooler on the study.
And the patients on the study as you correctly mentioned.
Oh, Madhu the cell versus standard Cork and so those.
The data from our study could be analyzed and quantified and that's what will be presented at ash now at the same time, we are doing additional H O. Our analyses using Saturday MTR databases and other sources.
Sources of.
Information to look at the broader context of the AQR benefit.
Potentially from I'm going to oversell them those will be presented at a later date and additional meetings that we'll update you about when were okay.
Thanks, Alright.
The final final question.
Maybe turning to Michelle.
In regards to to eat your Julien.
I'm sorry, Jonathan you had a third part of your question have we answered.
I think you got most of it guys. Thank you so much I mean I get it.
The detail on the ATR, what I was what I was hoping for was some color around.
What you already knew versus other graph sources.
Look forward to seeing the specifications on their available mhm.
Okay. Thank you.
Welcome.
Yes.
Yeah.
Your next question comes from Jason Butler of JMP Securities. Your line is now open.
Hi, it's Roy on for Jason Thanks for taking our questions I mean, I guess the first one just to stay.
Stay on the old <unk> BLA I guess, we thought the FDA was looking for clinical comparability as part of it.
The request.
Did they did they change their mind and did they explain why they changed their mind. If they did and did you showed agency any clinical data from the commercial product.
Okay.
Yes, they did change their guidance to us and.
I'll ask Jess to elaborate I don't think they.
Justified.
Why they changed their mind, but I think it's.
Commonly understood and expected that if you have analytical comparability that should lead to clinical comparability.
And we do have an expanded access program. So we will continue to collect data and obviously all of those data will be shared with FDA in real time.
Jan do you have anything further to add.
Thank you Julian so yes, absolutely compatibility is a really important topic and keep them moving forward any new manufacturing facility.
We had plans to proactively.
With the FDA and had justify to them that clinical data should not be required for Nathan facility SBA has come back and agreed with a proposition that clinical data not required for submission of the BLA, but they have asked us to we put them together they took with compatibility.
He said he had new analysis.
Okay, great. Thank you.
The city poster for GDA 201.
With the machine learning components pretty interesting it sounds like you can apply some of that.
To inform the development of the future and K candidates can you give us any specifics on how you might apply those.
And then as far as the Ash two year follow up for GDA 201, any changes of how you see that product potentially.
Sitting in the treatment paradigm, particularly with the duration.
Okay, Let me take the first part.
AI learning so what we really have done is detailed transcriptional profiling and metabolic profiling and then theres a.
Program called ingenuity, which is an AI learning tool, which classifies pathways in this pathway analysis.
And in so doing.
Can inform.
The transcript.
Data into this machine learning.
Approach.
Which surveys all literature, all references et cetera, and built on the development of <unk>.
Different biochemical pathways.
In the cell as well as the metabolite pathways. So yes, it can be applied and should be applied to every cellular product because there are a lot of things going on.
During the cell culture period, and particularly with our Nam enabled.
Activity, we are drastically affecting gene expression in a positive way to make the cells more potent and more useful.
Let me turn it to.
Rooney to talk about.
Ash.
Yeah and.
If I could add something to your comments about the artificial intelligence mediate analysis at that.
The entire platform.
NK cell.
We've been.
We've been discussing is.
Based on the NAND enabled.
K products and so understanding the mechanism of the differential expression induced by Nam helps us in the development of all the genetically modified.
And K construct so specific specific.
Formation will be used in the development of those contract with respect to the ash presentation on GDA 201, we continue to update the information on the patient. So we we had patients who have been treated now up to a little over three years and so what we will show.
In the presentation will be information patient by patient are where those patients are after treatment and this gives us further confidence.
In the duration and potential.
Efficacy of GDA 201, with our company sponsored study.
The cryopreserved formulation. So it just gives us further confidence in the product.
Yeah.
Great. Thank you.
Okay.
Your next question comes from Gregory <unk> of RBC capital markets. Your line is now open.
Good morning, Julien team. Thank you for the update and thanks for taking my question.
Julien certainly in light of the.
On the <unk> delay and a lot going on for Dmitry. So just curious if you could comment on how these developments do affect your overall approach to the larger portfolio certainly without him ideally sell and GDA 201 through through 601.
What are you looking at what inputs are you either waiting for just as far as how you are planning to allocate resources and you certainly mentioned the reassessment of <unk>.
<unk> planning, but as far as your thing Youre thinking around the portfolio in totality any comments would be appreciated. Thank you.
Yeah.
Obviously.
First and foremost we have to redress.
The FDA comments and get back on track with our submissions and the conduct of.
Future trials.
As we consider all of this.
We still have a strong cash position.
And the first and foremost it's going to be.
Dedicated towards the enablement of them <unk> GDA 201.
For.
Programs that are further back.
In.
Not yet.
Preclinical development stage.
The expenses can be very easily managed it's a low it's not a.
Burdensome.
The process for us to be able to prosecute those.
But of course, as we said, we're still reassessing and.
Still need to determine our timelines and our allocation of capital in a responsible way.
That's helpful. Thank you and maybe just one last one as you think about <unk>.
Capturing value from a deeper sell X X U S. I'm just curious if you could provide us an update on where your thinking is as far as partnerships.
Or a regulatory advancements in those regions. Thanks again Glenn.
I'm glad for this question because we have actually studied the ex U S territories, and let me turn it over to Michelle to provide some insights we have no. Thank you very much so I'm going to pause so ex U S is a very encouraging commercial opportunity in parts of Western Europe and in Asia, specifically, Japan.
Although we do see an opportunity from a <unk> to improve outcomes across all graph sources for Japan in particular, you see about a third of the patients.
Utilizing cord blood is their transplant, so when Japanese physicians saw the head to head data versus cord from <unk>. So they were very very encouraged so in both western Europe, and Japan, we see an encouraging opportunity and we continue to partner very closely with Josh Hammer matches, our chief business officer, and others on our team around.
What's the appropriate way for patients to get access to <unk> outside of the U S. But I think the probably the key takeaway is just the opportunity is there and now how do we move forward in terms of allowing patients to have access Johnson and her team have had good dialogue with E. N. A already so we understand the regulatory path forward.
We look forward to continuing to advance those plans around allowing patients to eventually access I'm going to either sell outside of the U S. Following regulatory approvals.
And I would add to that Michele that.
Since we conducted the phase III is an international study.
Sites in Europe.
I think we have.
The ability to file.
In Europe without additional studies.
For the adult population.
Japan.
It was a little bit trickier because there.
There are unique laws in Japan that would have us.
Required to do a potential bridging study, but all of those are just tactical issues and can be addressed.
That's helpful. Thanks, Julian Thanks, Michelle.
Your next question comes from Nick <unk> Gandhi of Needham and company. Your line is now open.
Hi, Good morning, Thank you for taking my question.
Another question related to the GDA 201 data presented at <unk>.
The results show that there is a decrease in CTO 16 expression with Nam cultivation compared with the standard NK cells.
This would be a potential issue for gd equals or alone.
Yes, let me begin and then turn it over to Ronnie is well.
First of all the decrease in CD 16 is very modest.
We still see high levels of <unk> 16.
To address this and to mitigate this variability in CD 16 expression, we are proposing quite.
Quite high doses in terms of sales.
Cells per kilo.
To overcome the donor to donor variability.
Ronnie do you have anything to add.
Yeah, I would say I would reiterate that it was a.
Minimal decrease in ambition in the context of an overall active non exhausted phenotype.
Sales are quite active.
And so that that mitigates any of this somewhat slight decreases.
Yeah.
In terms of killing potential et cetera.
Great.
And again, we extrapolate that that was borne out in the Minnesota data and obviously, we will look for the same act.
Activities.
As we see.
Comparable.
Comparably potent active NK cells and the Cryopreserved formulation.
Great. Thank you.
Yeah.
As a reminder to ask a question you will need to press star one on your telephone keypad.
Question comes from Mark Breidenbach of Hubei timer.
Your line is now open.
Hey, good morning, guys and thanks for the update just a quick one from me with regard to the BLA filing.
Can we reasonably assume that a another type b meeting will have to be scheduled with the FDA before before our submission.
Or is it kind of a situation where you can do the analysis and provide the data you need and then just submit the BLA without without a separate meeting thanks.
Yes, I think we have a very good perspective on that and let me ask add ask sorry Jess.
To talk about our filing approach.
Thank you Julian so yes, we have requested a type b meeting to discuss the analytical comparability data and that after we're not anticipating an additional type b meeting equivalent to a pre BLA FCA have guided us that we just need to submit an amendment to the I M D.
Rather than a type b meeting for that particular outcome.
Okay Super helpful. Thank you.
No further questions I would like to turn the call back to Mr. Julian Adams.
I want to thank everyone, who joined us on the call today.
<unk>.
It is really a pivotal time for <unk> to sell.
We have had FDA issues no doubt.
They are very technical in nature.
And very addressable and we are working hard too.
To attend to that.
Over and beyond that I think the team is extremely dedicated and hard working and.
I can't express enough gratitude.
Two the whole gamete yourself family.
For their dedication.
Additionally.
I also want to thank.
Patients and their families who have participated in our clinical studies.
And have you know.
Really donated to the benefit of.
Our medical knowledge.
And that I hope will prove.
Extremely beneficial to the medical community going forward.
And thank you all for your attention this morning.
This concludes today's conference. Thank you everyone for joining.
Okay.
Yeah.
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